A Pharmaco-surgical Approach to Reduce Postoperative Atrial Fibrillation After Cardiac Surgery

NCT ID: NCT05780320

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 242 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-19
• Study Completion Date: 2025-03-15

Brief Summary

Postoperative atrial fibrillation (POAF) is a common complication following cardiac surgery with an estimated incidence around 35%. It has been found to be an independent predictor of 30-day and 6-month mortality, stroke, renal failure, respiratory failure, and need for permanent pacemaker among others. Previous studies including meta-analyses demonstrate a protective benefit of prophylactic amiodarone to decrease the risk of POAF. However, this has not been widely adopted, and recent society guidelines only give prophylactic amiodarone a Class IIA recommendation, citing risk of amiodarone-related toxicity and hypotension as reasons for the Class IIA recommendation. A meta-analysis comparing cumulative doses of amiodarone found that moderate to higher doses of amiodarone have a marginally increased benefit in reducing the incidence of postoperative atrial fibrillation over lower doses; however, the study did not assess risk of complications stratified by cumulative doses, which has been previously described. Finally, a recent meta-analysis showed that a posterior pericardiotomy was highly effective at reducing postoperative atrial fibrillation. Consequently, the investigators' institution has adopted a pharmaco-surgical approach (prophylactic amiodarone and posterior pericardiotomy) in an effort to reduce postoperative atrial fibrillation after coronary artery bypass cardiac surgery for all patients who meet inclusion/exclusion criteria.

Conditions

Atrial Fibrillation New Onset

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Pharmaco-Surgical Arm

Prophylactic amiodarone and posterior pericardiotomy

Intervention Type: OTHER

Patients after the implementation of the protocol receive postoperative prophylactic amiodarone and a posterior pericardiotomy.

The amiodarone regimen consists of amiodarone 1mg/min x 10 hours (600 mg total) via central line upon arrival to the intensive care unit followed by 400 mg PO BID on postoperative days 1 and 2 followed by 200 mg PO BID on postoperative days 3 and 4 or until discharge, whichever occurs first.

The posterior pericardiotomy occurs during the cardiac procedure.

Standard of Care Arm

No interventions assigned to this group

Interventions

Prophylactic amiodarone and posterior pericardiotomy

Patients after the implementation of the protocol receive postoperative prophylactic amiodarone and a posterior pericardiotomy.

The amiodarone regimen consists of amiodarone 1mg/min x 10 hours (600 mg total) via central line upon arrival to the intensive care unit followed by 400 mg PO BID on postoperative days 1 and 2 followed by 200 mg PO BID on postoperative days 3 and 4 or until discharge, whichever occurs first.

The posterior pericardiotomy occurs during the cardiac procedure.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Preoperative normal sinus rhythm
• Procedures:
• CABG
• CABG + concomitant valve or aortic replacement/repair

Exclusion Criteria

• Emergent operation

Procedures:

• MAZE or PVI performed
• Isolated valve replacement or repair
• Isolated aortic procedures
• Heart transplant
• Lung transplant Pre-existing atrial arrhythmias Pre-operative amiodarone use Contraindications to amiodarone use
• PR interval > 240 ms
• 2nd or 3rd degree heart block
• QTc > 550ms
• 2nd or 3rd degree heart block
• Liver impairment (INR > 1.7, AST/ALT > 2x normal)
• Uncontrolled hypothyroidism/hyperthyroidism
• Interstitial lung disease
• Allergy to amiodarone

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Asishana A Osho

Assistant Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Asishana A Osho, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

Greenberg JW, Lancaster TS, Schuessler RB, Melby SJ. Postoperative atrial fibrillation following cardiac surgery: a persistent complication. Eur J Cardiothorac Surg. 2017 Oct 1;52(4):665-672. doi: 10.1093/ejcts/ezx039.

Reference Type: BACKGROUND

PMID: 28369234 (View on PubMed)

Arsenault KA, Yusuf AM, Crystal E, Healey JS, Morillo CA, Nair GM, Whitlock RP. Interventions for preventing post-operative atrial fibrillation in patients undergoing heart surgery. Cochrane Database Syst Rev. 2013 Jan 31;2013(1):CD003611. doi: 10.1002/14651858.CD003611.pub3.

Reference Type: BACKGROUND

PMID: 23440790 (View on PubMed)

Chatterjee S, Sardar P, Mukherjee D, Lichstein E, Aikat S. Timing and route of amiodarone for prevention of postoperative atrial fibrillation after cardiac surgery: a network regression meta-analysis. Pacing Clin Electrophysiol. 2013 Aug;36(8):1017-23. doi: 10.1111/pace.12140. Epub 2013 Apr 29.

Reference Type: BACKGROUND

PMID: 23627761 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 17316148 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 19597088 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 19399307 (View on PubMed)

Gaudino M, Sanna T, Ballman KV, Robinson NB, Hameed I, Audisio K, Rahouma M, Di Franco A, Soletti GJ, Lau C, Rong LQ, Massetti M, Gillinov M, Ad N, Voisine P, DiMaio JM, Chikwe J, Fremes SE, Crea F, Puskas JD, Girardi L; PALACS Investigators. Posterior left pericardiotomy for the prevention of atrial fibrillation after cardiac surgery: an adaptive, single-centre, single-blind, randomised, controlled trial. Lancet. 2021 Dec 4;398(10316):2075-2083. doi: 10.1016/S0140-6736(21)02490-9. Epub 2021 Nov 14.

Reference Type: BACKGROUND

PMID: 34788640 (View on PubMed)

Other Identifiers

2004P001528

Identifier Type: -

Identifier Source: org_study_id